Reversible Cap For Pen Needle Outer Cover

ABSTRACT

A pen needle assembly includes a cap for covering the non-injection end of a needle of a pen needle. The needle is received by a hub, which is disposed in an outer cover. The cap is adapted to be connected to the outer cover in a first or second position. The cap is removable in the first position and the cap is locked to the outer cover in the second position.

FIELD OF THE INVENTION

The present invention relates to a reversible cap for covering anon-patient end of the needle. More particularly, the present inventionrelates to a reversible cap that provides a sharps container whenconnected to an outer cover.

BACKGROUND OF THE INVENTION

In certain circumstances, it is desirable to inject medication directlyinto human tissue. Typically, syringes or pen injection devices are usedto inject medicaments into tissue areas, such as the intramusculartissue layer, the subcutaneous tissue layer, and the intradermal tissuelayer.

The assembly and operation of a typical pen injection device, as shownin FIGS. 1 and 2, is described in U.S. Patent Application PublicationNo. 2006/0229562, published on Oct. 12, 2006, which is herebyincorporated by reference in its entirety.

Pen injection devices, such as the exemplary pen injector 100, as shownin FIG. 1, typically comprise a dose knob/button 24, an outer sleeve 13,and a cap 21. The dose knob/button 24 allows a user to set the dosage ofmedication to be injected. The outer sleeve 13 is gripped by the userwhen injecting medication. The cap 21 is used by the user to securelyhold the pen injector device 100 in a shirt pocket, purse or othersuitable location.

FIG. 2 is an exploded view of an exemplary drug delivery pen shown inFIG. 1. The dose knob/button 24 has a dual purpose and is used to bothset the dosage of the medication to be injected and to inject the dosedmedicament via the lead screw 7 and stopper 15 through the medicamentcartridge 12, which is attached to the drug delivery pen through a lowerhousing 17. In standard drug delivery pens, the dosing and deliverymechanisms are all found within the outer sleeve 13 and are notdescribed in greater detail here as they are understood by thoseknowledgeable of the prior art. The distal movement of the plunger orstopper 15 within the medicament cartridge 12 causes medication to beforced into the needle 11 of the hub 20. The medicament cartridge 12 issealed by septum 16, which is punctured by a septum penetrating needlecannula 18 located within the hub 20. The hub 20 is preferably screwedonto the lower housing 17, although other attachment means can be usedsuch as attaching to the cartridge. To protect a user, or anyone whohandles the pen injection device 100, an outer cover 69, which attachesto the hub 20, covers the hub. An inner shield 59 covers the patientneedle 11 within the outer cover 69. The inner shield 59 can be securedto the hub 20 to cover the patient needle 11 by any suitable means, suchas an interference fit or a snap fit. The outer cover 69 and innershield 59 are removed prior to use. The cap 21 fits snugly against outersleeve 13 to allow a user to securely carry the drug delivery pen 100.

The medicament cartridge 12 is typically a glass tube sealed at one endwith the septum 16 and sealed at the other end with the stopper 15. Theseptum 16 is pierceable by a septum penetrating cannula 18 in the hub20, but does not move with respect to the medicament cartridge 12. Thestopper 15 is axially displaceable within the medicament cartridge 12while maintaining a fluid tight seal.

A pen needle, which includes the hub 20, needle 11, outer shield 69 andinner shield 59, is typically used for a single injection and is thendisposed of. Following an injection, the used needle, or “sharps”, mustbe properly disposed of. Used sharps may become contaminated by bodyfluids and the like creating a hazard for anyone that may handle themfollowing their use. Sharps disposal containers store the disposedsharps and prevent unintentional contact with any object disposedtherein. Accordingly, a need exists for a cap for an outer cover thatcompletely encapsulates the pen needle within a puncture resistant coverand cap after use.

Another problem is properly handling a used needle while avoiding anaccidental needle stick or contamination. Pen needle outer covers aretypically sealed by a foil seal that is discarded after opening theouter cover to access the hub assembly. Accordingly, a need exists for acap that seals the outer cover both before and after using the needle.

SUMMARY OF THE INVENTION

In accordance with an aspect of the present invention, a reversible capconnects to an outer cover in a first position before the needle is usedand in a second position after the needle is used.

In accordance with another aspect of the present invention, oppositefaces of the cap have different indicia to indicate the condition of thepen needle contained therein.

A pen needle assembly according to an exemplary embodiment of thepresent invention includes a cap for covering the non-injection end of aneedle of a pen needle. The needle is received by a hub, which isdisposed in an outer cover. The cap is adapted to be connected to theouter cover in a first or second position. The cap is removable in thefirst position and the cap is locked to the outer cover in the secondposition.

Objects, advantages, and salient features of the invention will becomeapparent from the following detailed description, which, taken inconjunction with the annexed drawings, discloses exemplary embodimentsof the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The above benefits and other advantages of the various embodiments ofthe present invention will be more apparent from the following detaileddescription of exemplary embodiments of the present invention and fromthe accompanying figures, in which:

FIG. 1 is a perspective view of an assembled existing pen needleassembly;

FIG. 2 is an exploded perspective view of the components of the penneedle assembly of FIG. 1;

FIG. 3 is a perspective view of a reversible cap for a pen needle outercover according to an exemplary embodiment of the present invention;

FIG. 4 is a perspective view of the other side of the reversible cap ofFIG. 3;

FIG. 5 is a perspective view of the cap of FIG. 3 connected to an outercover;

FIG. 6 is an exploded perspective view of cap and pen needle of FIG. 5in which the cap has been reversed;

FIG. 7 is a perspective view of a reversible cap according to anotherexemplary embodiment of the present invention;

FIG. 8 is a perspective view of the other side of the reversible cap ofFIG. 7 with the removable flange removed;

FIG. 9 is a perspective view of the cap of FIG. 7;

FIG. 10 is a perspective view of the cap of FIG. 7 sealed to an outercover;

FIG. 11 is a perspective view of the cap of FIG. 7 in which the tab islifted to break the seal with the outer cover;

FIG. 12 is a perspective view of the cap of FIG. 7 after having beenremoved from the outer cover;

FIG. 13 is a perspective view of the cap of FIG. 7 with the tab securedto a first face of the cap; and

FIG. 14 is a perspective view of the cap of FIG. 7 showing a second facethereof.

Throughout the drawings, like reference numbers will be understood torefer to like parts, components and structures.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

In an exemplary embodiment of the present invention, as shown in FIGS.3-6, a cap 101 covers a non-patient end 147 of the needle 149 of the penneedle 141 before and after using the needle for an injection. The cap101 has a first surface 103 and a second surface 105. The cap 101 isconnectable to an outer cover 169 of the pen needle 141 in either afirst position in which the first surface is visible as shown in FIG. 3or in a second position in which the second position is visible as shownin FIG. 4. The first surface 103 has indicia 104 indicating that theneedle 103 has not yet been used for an injection. The second surface105 has indicia 106, such as a contaminated sharps symbol, indicatingthat the needle has been used for an injection.

The cap 101 has an outer side wall 107 having a first end 108 and asecond end 109. A first lip 117 extends inwardly from the first end 108of the side wall 107, and a second lip 118 extends inwardly from asecond end 109 of the side wall 107. A first inner side wall 110 extendsfrom the second surface 105 to the first end. A second inner side wall111 extends from the first surface 103 to the second end 109. Aplurality of ribs 113 extend axially along the first inner side wall110. The ribs 113 extend from the second surface 105 to the first lip117. A plurality of tabs 115 are disposed circumferentially around thesecond inner side wall 111. A handle 119 extends outwardly from theouter side wall 107 to facilitate gripping the cap 101.

The cap 101 is initially connected to the outer cover 169 in a firstposition, as shown in FIG. 5, such that the first surface 103 isvisible. The indicia 104 on the first surface 103 indicate that theneedle has not yet been used for an injection. The ribs 113 create aninterference fit with the flange 171 of the outer cover 169. When aninjection is to be made, a user grips the handle 119 and lifts thehandle away from the outer cover 169, thereby removing the cap 101 fromthe outer cover. The pen needle 151 may then be connected to a peninjection device 100 (FIGS. 1 and 2) to perform an injection.

After injecting a medicament, an inner shield 159 may optionally bedisposed over the patient end of the needle 149 to shield thepatient-end of the needle and prevent an accidental needle stick. Thehub 151 and inner shield 159, if used, are then disposed in the outercover 169. The cap 101 is reversed and connected to the outer cover 169in a second position, as shown in FIG. 6. As the cap 101 is pusheddownwardly on the outer cover 169, the sloped portion 121 of the tabs115 pass over the flange 171, thereby locking the flange between thetabs 115 and the first surface 103 of the cap 101. The flat portion 123of the tab 115, which is substantially parallel to the first surface103, prevents the tab 115 from passing over the flange 171, therebysecurely locking the cap 101 to the outer cover 169 and providing asharps container. The second indicia 106 on the second surface 105 ofthe cap 101 is visible when the cap 101 is locked in the secondposition. The second indicia 106 indicate that the needle has been usedfor an injection, and such indicia could include a contaminated sharpssymbol, as shown in FIG. 3.

In another exemplary embodiment, as shown in FIGS. 7-14, a reversiblecap 201 is connectable to an outer cover 169 (FIG. 6) of a pen needle ina first or second position. The cap 201 has a first surface 203 that isvisible when the cap 201 is connected to the outer cover in the firstposition. A second surface 205 of the cap 201 is visible when the cap isconnected to the outer cover in the second position.

A sealing wall 211 extends upwardly from the first surface 203 of thecap 201, as shown in FIG. 7. An opening 212 is formed in the wall 211. Aremovable flange 213 surrounds the sealing wall 211. A notch 214 isformed between the flange 213 and the first surface 203 to facilitateremoving the flange 213. A tab 217 extends outwardly from the firstsurface 203 and is preferably substantially planar with the firstsurface 203. A groove 218 is formed in the tab 217 to facilitate flexingof the tab about the groove 218. Indicia 219 are disposed on the secondsurface 205 of the cap 201, as shown in FIG. 8, to indicate that theouter cover has been opened.

FIGS. 9-14 illustrate opening and resealing the outer cover 169 with thecap 201, as shown in FIG. 9. The cap 201 is connected to the outer coverduring the manufacturing process. The removable flange 213 of the cap201 is connected to the flange 171 of the outer cover 169, preferably byultrasonic welding or bonding, in the first position such that the firstsurface 203 is visible, as shown in FIG. 10. The tab 217 is bent aroundthe groove 218 such that the tab is adjacent the outer cover.

When the outer cover is to be opened the tab 217 is lifted upwardly andaway from the outer cover, as shown in FIG. 11. The flange 213 is thenseparated from the cap 201 along the notch 214, thereby breaking theseal between the cap 201 and the outer cover. The cap 201 is thenremoved from the outer cover and the tab 217 is pushed downwardly towardthe first surface 203 of the cap 201, as shown in FIG. 13, and the tab217 is received by the opening 212 in the sealing wall 211. When theinjection has been made and the used pen needle is returned to the outercover, the cap 201 is connected to the outer cover in the secondposition such that the second surface 205 is visible. The cap 201 ispushed downwardly such that the sealing wall 211 forms a seal with theouter cover. In the second position, the indicia 219 on the secondsurface 205 of the cap 201 is visible to indicate that the pen needlehas been used for an injection. Such indicia could include “NONSTERILE”, as shown in FIGS. 8 and 14, but any suitable indicia may beused.

The foregoing embodiments and advantages are merely exemplary and arenot to be construed as limiting the scope of the present invention. Thedescription of exemplary embodiments of the present invention isintended to be illustrative, and not to limit the scope of the presentinvention. Various modifications, alternatives and variations will beapparent to those of ordinary skill in the art, and are intended to fallwithin the scope of the invention as defined in the appended claims andtheir equivalents.

1. A pen needle assembly, comprising: a needle; a hub for receiving saidneedle; an outer cover receiving said hub; and a cap adapted to beconnected to said outer cover in a first or second position, said capbeing removable in said first position and said cap being locked to saidouter cover in said second position.
 2. The pen needle assembly of claim1, wherein said cap has first and second surfaces having differentindicia thereon indicating whether said cap is connected to said outercover in said first or second position.
 3. The pen needle assembly ofclaim 1, wherein a plurality of ribs extend axially along a first innerside wall of said cap to facilitate connecting said cap to said outercover in said first position.
 4. The pen needle assembly of claim 1,wherein a plurality of tabs are disposed on a second inner side wall ofsaid cap to lockably receive a flange of said outer cover in said secondposition.
 5. The pen needle assembly of claim 1, wherein a handleextends outwardly from said cap.
 6. The pen needle assembly of claim 2,wherein said indicia indicating said cap is in said second positioncomprises a contaminated sharps symbol.
 7. The pen needle assembly ofclaim 2, wherein said indicia indicating said cap is in said firstposition indicates said needle has not been used for an injection.
 8. Areversible cap for a pen needle outer cover, comprising: a base having afirst surface and a second surface; a first inner side wall extendingsubstantially perpendicularly from said second surface; and a secondinner side wall extending substantially perpendicularly from said firstsurface, wherein said cap is connectable to an outer cover of a penneedle in a first position such that said first surface is visible or ina second position such that said second surface is visible.
 9. Thereversible cap of claim 8, wherein a plurality of ribs extend axiallyalong said first inner side wall to facilitate connecting said cap tothe outer cover in said first position.
 10. The reversible cap of claim8, wherein a plurality of tabs are disposed on said second inner sidewall cap to lockably receive a flange of the outer cover in said secondposition.
 11. The reversible cap of claim 8, wherein first indiciadisposed on said first surface indicate said cap is in said firstposition and that said needle has not been used for an injection. 12.The reversible cap of claim 8, wherein second indicia disposed on saidsecond surface indicate said cap is in said second position comprises acontaminated sharps symbol
 13. The reversible cap of claim 12, whereinsecond indicia comprise a contaminated sharps symbol.
 14. A reversiblecap for a pen needle assembly, comprising: a base having a first surfaceand a second surface; a sealing wall extending upwardly from said firstsurface of said base; and a removable flange removably connected to saidbase, wherein cap is adapted to be connected to an outer cover of a penneedle in a first or second position, said first surface being visiblewhen said cap is connected to the outer cover in said first position andsaid second surface being visible when said cap is connected to saidouter cover in said second position.
 15. The reversible cap of claim 14,wherein said removable flange is separated from said cap to remove saidcap from the outer cover when said cap is in said first position. 16.The reversible cap of claim 14, wherein indicia are disposed on thesecond surface of the cap and are visible when said cap is connected tosaid outer cover in said second position to indicate that a needle ofthe pen needle has been used.
 17. The reversible cap of claim 14,wherein a handle is connected to said base to facilitate removing saidcap from the outer cover when said cap is in said first position. 18.The reversible cap of claim 17, wherein said handle is received by anopening in said sealing wall after said cap has been removed from theouter cover.
 19. The reversible cap of claim 14, wherein said sealingwall is received by the outer cover when said cap is connected to saidouter cover in said second position.
 20. The reversible cap of claim 14,wherein said cap is connected to the outer cover in said first positionby ultrasonic welding or bonding.